Prospective Data Bank Creation to Study Vaginal Conditions (CRI-PB-13-002)
The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||12 Months|
|Official Title:||A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach|
- Cytokines Determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ] [ Designated as safety issue: No ]To determine types of cytokines normally present in women's vagina and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
- Proteins Determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ] [ Designated as safety issue: No ]The vaginal milieu will respond to the insult by developing an inflammatory reaction characterized by protein production (in terms of increased protein concentration according to the Bradford protein assay).
- Lactobacillus determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ] [ Designated as safety issue: No ]Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing lactobacillus microflora alteration.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Non pregnant asymptomatic
Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination
Non pregnant symptomatic
Non-pregnant women ages 12 to 75 years being evaluated for any gynecological vulvovaginal condition.
Pregnant women ages 12 to 75 years who are both asymptomatic and healthy
Pregnant women ages 12 to 75 who have any gynecological vulvovaginal condition
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829204
|United States, Texas|
|TTUHSC Permian Basin||Recruiting|
|Midland, Texas, United States, 79701|
|Contact: Jennifer R Hinojosa, RN 432-335-5113 firstname.lastname@example.org|
|Principal Investigator: Gary Ventolini, MD|
|Principal Investigator:||Gary Ventolini, MD||TTUHSC PB|